DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 112 –
Indefiniteness and Indefinite Language
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 7 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 7, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The Applicant is encouraged to remove the indefinite language.
Claim Rejections - 35 USC § 103 - Obviousness
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-7, 11-12 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Obara et al (JP2012056896A), in view of Sato et al (Journal of Controlled Release, 266, 2017, 216-225).
Obara taught a method for treating refractory hepatitis virus infections [abstract; hepatitis B (HBV) at the 2nd page and 2nd paragraph], comprising administering [page 2, 1st paragraph] a drug carrier useful for transferring a drug into a cell, a complex containing poly-I or poly-I analog and poly-C or poly-C analog, or a drug useful for transferring a drug into a cell. Examples of the drug carrier included at least one selected from the group consisting of cationic liposomes, atelocollagen and nanoparticles [page 2, section entitled (1)].
At page 5, 3rd paragraph, Obara taught that the therapeutic agent and inducer of the present disclosure were effective for animals including humans, and particularly effective when acting on hepatocytes. The therapeutic agent was produced by mixing, stirring, dispersing, etc. a drug carrier and its raw material compounds, by conventional methods (e.g., reads on encapsulating within a drug carrier) [page 4, 2nd paragraph under section 4].
Although, Obara generally taught drug carriers (e.g., nanoparticles) comprising therapeutic agents effective when acting on hepatocytes, Obara was not specific the surface of the carrier conjugated with a molecule accumulating in hepatocytes, as recited in claim 1.
Sato taught nanoparticles modified with a hepatocyte-specific ligand, N-acetyl-b-galactosamine (GalNAc), which substantially improved hepatocyte-specificity [abstract]. A single injection of the particles resulted in a significant reduction of HBV in mice with humanized livers that had been persistently infected with HBV (e.g., reads on ability to accumulate in hepatocytes) [abstract].
Since Obara generally taught drug carriers comprising therapeutic agents effective when acting on hepatocytes, it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Obara, conjugation on the surface of Obara’s drug carriers with a molecule accumulating in hepatocytes, as taught by Sato. The ordinarily skilled artisan would have been motivated to improve hepatocyte specificity, as taught by Sato at the abstract.
Obara, in view of Sato, reads on claims 1-3 and 5-6.
Claim 4 is rendered prima facie obvious because Obara taught the chain lengths of poly-I, poly-I analog, poly-C and poly-C analog, each independent of each other, and within the range of 100 to 600 bases [page 3, 1st paragraph].
The instant claim 4 recites a base range of 50 to 1000 bases.
Obara taught 100 to 600 bases. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", a prima facie case of obviousness exists. MPEP 2144.05 A.
Claim 7 is rendered prima facie obvious because Obara taught poly A or poly A analogs and poly U or poly U analogs [page 2, section entitled (1); see also the abstract].
Claims 11-12 and 23 are rendered prima facie obvious because Obara taught inducing IFNλ, at the abstract [see also the last paragraph of page 1; 4th-5th paragraphs of page 2; 1st 3 paragraphs of page 3; section entitled 1. Summary of the invention at page 3; page 4, section 3 to page 6].
At page 5 [section entitled confirmation of anti-hepatitis virus effect [1 and 2], Obara taught: A human liver chimera mouse was infected with genotype HBV. The test solution was administered. The therapeutic agent decreased the amount of HBV genomic DNA in the liver (Fig. 1e).
Conclusion
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/CELESTE A RONEY/Primary Examiner, Art Unit 1612
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